Guo's Renovisceral Artery Reconstruction-1: a Prospective, Multicenter, Single-arm Clinical Trial to Evaluate the Safety and Efficacy of a Multi-branched Stent Graft System for Thoracoabdominal Aortic Aneurysm (GUARANTEE Study)
Sponsor study identifier
interventional
73
1 country
1
Study Start
November 12, 2021
Actual (reported)Primary Completion
December 31, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Evaluation of the safety and efficacy of a multi-branched thoracoabdominal stent graft system for thoracoabdominal aortic aneurysm.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 7, 2021
Actual (reported)September 23, 2021
Actual (reported)November 12, 2021
Actual (reported)December 31, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Primary safety endpoint: The incidence of Major Adverse events (MAE) within 30 days after procedure.
Major Adverse Event (MAE) was defined as all-cause death, liver failure, intestinal necrosis, kidney failure, stroke, permanent paraplegia, myocardial infarction, and respiratory failure.
Within 30 days after procedure
Primary efficacy endpoint: Success rate of thoracoabdominal aortic aneurysm treatment 12 months after procedure.
Successful treatment of thoracoabdominal aortic aneurysm is a composite index that needs to meet the following indicators at the same time: Immediate technical success (immediate technical success refers to the successful delivery system to a predetermined location, the successful deployment of the system and the safe withdrawal of the delivery system from the body and no type I/III endoleak), no secondary surgical intervention related to thoracoabdominal aortic aneurysms 12 months after procedure (due to aneurysm rupture, continuous enlargement, stent displacement, type I/III endoleak, branch stenosis/ Second surgery caused by occlusion) .
12 months after procedure.
aneurysmal enlargement at 6 and 12 months postoperatively
6 and 12 months postoperatively
type I/III endoleak at 6 and 12 months postoperatively
6 and 12 months postoperatively
stent graft migration at 6 and 12 months postoperatively
6 and 12 months postoperatively
renovisceral artery patency rate at 6 and 12 months postoperatively
6 and 12 months postoperatively
reintervention secondary to TAAA progression at 6 months, 12 months, and 2-5 years postoperatively.
6 months, 12 months, and 2-5 years postoperatively.
Patients with thoracoabdominal aortic aneurysms, and passed the screening and signed the informed consent form.
Patients who meet all the inclusion criteria and don't meet the exclusion criteria will be implanted with multi-branched thoracoabdominal stent graft system .
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Chinese PLA General Hospital
Beijing, Beijing Municipality, China
Ge Y, Zhang H, Rong D, Liu F, Jia X, Xiong J, Ma X, Wang L, Fan T, Guo W. Protocol for GUo's renovisceral Artery reconstruction-1: a prospective, multicentre, single-arm clinical trial to evaluate the safety and efficacy of a multibRANched sTEnt graft systEm for thoracoabdominal aortic aneurysm (GUARANTEE study). BMJ Open. 2022 Mar 23;12(3):e059401. doi: 10.1136/bmjopen-2021-059401.
Wei Guo, Professor
Chinese PLA General Hospital
First Submitted
September 7, 2021
First Posted
September 23, 2021
Study Start
November 12, 2021
Actual (reported)Primary Completion
December 31, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Physician-Modified Fenestrated and Branched Aortic Endografting for TAAA
Contact the study team to confirm eligibility.
Study Completion
December 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
June 22, 2025
Record last verified: 2025-06
The data will be shared for scientific purposes after the completion of the clinical trial. However, patients' electronic records and any CTA files are outside the scope of our data sharing policy. Researchers wanting to request data can submit a detailed application to the investigators. Data will be released depending on the scientific quality of the submitted request.
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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